Bleomycin, Etoposide, and Cisplatin in Treating Patients With Metastatic Germ Cell Cancer of the Testicles

Testicular Germ Cell Tumor Clinical Trial

Official title:

A Randomized Phase III Toxicity Study of Day 2, 3, 8, 15 Short (30 Minute) Versus Day 1, 2, 3 Long (72 Hours) Infusion Bleomycin for Patients With IGCCCG Good Prognosis Germ Cell Tumors, TE3

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00324298
• Other study ID #: BARTS-TE3
• Secondary ID: CDR0000472976EU-
• Status: Completed
• Phase: Phase 3
• First received: May 10, 2006
• Last updated: August 9, 2013
• Start date: July 2003
• Est. completion date: March 2011

Study information

• Verified date: January 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy, such as bleomycin, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known which schedule of bleomycin is more effective when given together with etoposide and cisplatin in treating metastatic germ cell cancer of the testicles.

PURPOSE: This randomized phase III trial is studying two different schedules of bleomycin to compare how well they work when given together with etoposide and cisplatin in treating patients with metastatic germ cell cancer of the testicles.

Description:

OBJECTIVES:

Primary

• Determine if long-infusion schedule of bleomycin is less toxic to the lungs than short-infusion schedule of bleomycin in patients who are undergoing combination chemotherapy comprising bleomycin, etoposide, and cisplatin for good-prognosis, metastatic germ cell cancer of the testes.

• Determine if early lung function tests are a predictor for late toxicity.

• Determine if any indication of enhanced response to the long-infusion schedule justifies a large-scale phase III evaluation.

• Validate the O'Sullivan et al prognostic scoring system for bleomycin toxicity.

Secondary

• Determine response to treatment.

• Determine progression-free survival and overall survival of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (≤ 30 years vs > 30 years), current smoker or has smoked within the past 1 year (yes vs no), and creatinine clearance (≤ 80 mL/min vs > 80 mL/min). Patients are randomized to 1 of 2 treatment arms.

• Arm I (short-infusion schedule of bleomycin): Patients receive etoposide IV over 2 hours on days 1-3, cisplatin IV over 4 hours on days 1 and 2, and bleomycin IV over 30 minutes on days 2, 8, and 15.

• Arm II (long-infusion schedule of bleomycin): Patients receive etoposide and cisplatin as in arm I. Patients also receive bleomycin IV continuously over 72 hours on days 1-3.

In both arms, treatment repeats every 3 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 4 weeks and then every 3 months for 24 months.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 210 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

DISEASE CHARACTERISTICS:

• Diagnosis of metastatic germ cell cancer of the testes

• Good-prognosis disease

• Eligible for treatment with bleomycin, etoposide, and cisplatin

PATIENT CHARACTERISTICS:

• Creatinine clearance = 60 mL/min

• No other prior or concurrent malignancy except basal cell skin cancer

• No other major systemic illness

• No impaired respiratory function, including any of the following:

• Shortness of breath on minimal exertion

• Hypoxia at rest

• Carbon monoxide transfer, total lung capacity, and FEV_1 > 60% of predicted

PRIOR CONCURRENT THERAPY:

• No prior chemotherapy or radiotherapy

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Drug/Agent Toxicity by Tissue/Organ
• Neoplasms, Germ Cell and Embryonal
• Testicular Germ Cell Tumor
• Testicular Neoplasms

Intervention

Biological:
• bleomycin sulfate

Drug:
• cisplatin

• etoposide

Procedure:
• management of therapy complications

Locations

Country	Name	City	State
United Kingdom	Basildon University Hospital	Basildon	England
United Kingdom	Addenbrooke's Hospital	Cambridge	England
United Kingdom	Essex County Hospital	Colchester	England
United Kingdom	Ipswich Hospital	Ipswich	England
United Kingdom	Leeds Cancer Centre at St. James's University Hospital	Leeds	England
United Kingdom	Saint Bartholomew's Hospital	London	England
United Kingdom	University College of London Hospitals	London	England
United Kingdom	Norfolk and Norwich University Hospital	Norwich	England
United Kingdom	Royal Marsden - Surrey	Sutton	England
United Kingdom	Southend University Hospital NHS Foundation Trust	Westcliff-On-Sea	England

Sponsors (1)

Lead Sponsor	Collaborator
Queen Mary University of London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary toxicity			Yes
Secondary	Response to treatment			No
Secondary	Progression-free survival			No
Secondary	Overall survival			No